Instructions For Use

Sira Medical
Augmented
Reality Applicationwww.siramedical.com@2023

Sira Medical Augmented Reality Application User Manual

Table of Contents
1. Sira Medical
1. Product Description

4

2. Intended Use

4

3. Indications for Use

4

4. Contraindications

4

5. Essential Functions

4

6. Intended User

5

7. Technical Specifications

5

3. Installation

2. Safety Advisory
1. Verify Information on Request Form

6

1. Installation10

2. Select the Appropriate Model and

6

2. Application Updates10

3. HoloLens 2 Environment

11

4. OneDrive Access

11

Manipulate Properly
3. Logging Off

7

4. Image Display

7

5. Critical Anatomy

7

6. Other Issues

7

7. Hazardous Situations Associated with

8

Use of Applications

4. Submitting Images for 3D Modeling

5. Getting Started with the Sira
Medical Augmented Reality Application

1. Establish Client Services

12

1. Network Configuration

14

2. Requesting a 3D Model

12

2. Sira Medical Augmented Reality

14

3. Receiving a completed 3D Model

12

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Application
3. Model Manipulation/360 Degree Tour17

4. Sizing and Resizing

17

5. Layer Visibility

18

6. Object Comparison

18

7. Virtual Cut

19

8. Adding Notes, Annotations, and Labels

20

9. Session Recording

21

10. Logging Off

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6. Troubleshooting

7. Maintenance1. Common Errors

22

1. Regular Maintenance26

2. Memory Overload Prevention

23

2. Sufficient Memory26

3. Sira Medical Augmented Reality

23

3. Cybersecurity End-of-Support

26

4. Product End-of-Life

26

Application Troubleshooting
4. OneDrive and Network Access25

5. Export Logs

27

Troubleshooting

8. Symbols
1. Symbols

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9. Contact Us
27

1. Contact us28© Sira Medical, Inc. 2023

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Sira Medical Augmented Reality Application User Manual

1. Sira Medical

1. Sira Medical
1 Product Description
The Sira Medical Augmented Reality Application and 3D Image Preparation Service provide accessto patient-specific images which allow greater anatomical clarity and fidelity than conventional CT
scans and MRIs. The application permits manipulation of the images to help clinicians preoperatively
plan for surgery and allows capture of video and still images for use in preoperative surgical planningoutside the application.

2 Intended Use
Sira Medical develops patient-specific images derived from the same data used to generate
conventional imaging such as CT scans, MRIs and other images to help with preoperative surgicalplanning. The Sira Medical Augmented Reality Application is designed to help users view andmanipulate these images.
Within preoperative surgical planning, the Sira Medical Augmented Reality Application and the images
viewed through the application are used by clinicians to review patient anatomy and evaluate surgicalpaths, among other activities, and are intended for use across a range of medical specialties.

3 Indications for Use
Sira Medical Augmented Reality Application is intended as a medical imaging system that allows theprocessing, review, analysis, and communication of augmented reality images acquired from thesame data used to generate conventional CT scans and MRIs. Sira Medical software is designed forpreoperative surgical planning and intended to be used by trained and qualified clinicians who areresponsible for making patient management decisions.

4 Contraindications
The Sira Medical Augmented Reality Application is not a diagnostic tool. The application is not to be
used for stereotactic or intraoperative procedures.

5 Essential Functions
The Sira Medical Augmented Reality Application is used in conjunction with the Sira 3D Image Preparation Service. The Sira 3D Image Preparation Service prepares image files for viewing within the Sira
Medical application. The 3D Image Preparation Service is operated by Sira Medical personnel, undercontrol of Sira Medical, using specified inputs, tools, and processes, to create 3D outputs from theuser’s radiological study images. The image files are delivered in .fbx format.
The Sira Medical Augmented Reality Application is used for viewing and manipulating 3D models created by the Sira 3D Image Preparation Service. The application allows the user to manipulate one ormore 3D models in real time in an Augmented Reality (AR) environment. The user can view the model, adjust the orientation, scale, rotate, and position the models within the AR visual space. Models
can be sliced to create separate objects or merged together to create a single object. Screenshots andvideo files can be captured using the HoloLens 2 platform and exported for use outside the application.
Note: The environment for the Sira Medical Augmented Reality Application is limited to
the Microsoft HoloLens 2 platform.

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1. Sira Medical

Models are accessed from a OneDrive location configured by the Sira 3D Image Preparation
Service. The Sira Medical Augmented Reality Application does not update the 3D model as stored;
all manipulations are local to the HoloLens 2 environment and are not preserved after the session
is closed. Still shots and video files created during manipulation of the model are stored local to the
HoloLens or on network locations to which the HoloLens has access.

6 Intended User
The intended user for the Sira Medical Augmented Reality Application are trained and qualified clinicians. User should be trained in the medical aspects of using and assessing radiology studies forpreoperative surgical planning. User should be familiar with the use of the HoloLens in an Augmented Reality (AR) environment, AR manipulation of objects, and Sira Medical application.

7 Technical Specifications
Technical specifications for the Sira Medical application below with the latest at: siramedical.com/hololens-technical-specifications/
Item

Minimum Requirement

HeadsetHoloLens 2 Mixed Reality Headset

HoloLens 2 Free Memory for
Sira Medical Application

1 GB

Operating system

Windows Holographic 22H1

Network connection

WiFi 5 or later including performance supporting
real time data synchronization, remote content
streaming and updating.

Cloud storage

OneDrive account

The Sira Medical Augmented Reality Application uses relative spacing information and does not provide measurement information for the models. Relative distance positioning information is displayed
in meters and relative angles are displayed in degrees.

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2. Safety Advisory

2. Safety Advisory
Warnings and Cautions indicate conditions or consequences that you should pay particular attention
to when working with Sira Medical applications and formulating a preoperative surgical plan.

1 Verify Information on Request Form

Warning!

Caution!

Submitting incorrect data can lead to a poor preoperative surgical plan. Double
check to make sure the information that is being submitted is correct. Always
maintain conventional imaging as a backup.

Make sure the information being submitted is anonymized. Always use the fieldin the Sira Medical Request Form to enter the anonymized Package ID and Source
Image ID(s).

2 Select the Appropriate Model and Manipulate Properly

Warning!

Warning!
No Package ID

Warning!

Warning!

Warning!

Selecting the wrong model will lead to an incorrect preoperative surgical plan.
Cross check the model package ID on the screen to make sure you are selecting thecorrect model file.

If the Sira Medical Image Preparation Service did not include a package ID or labeled it incorrectly, the Label will show “No Package ID”. Do not use a model withouta package ID as this could result in a preoperative surgical plan for the wrong patient. Contact Sira Medical Customer Service for model correction.
The Sira Medical application permits transparency of models to be adjusted fromcompletely transparent to completely opaque. Inadvertently making a model completely transparent can lead to an incorrect preoperative surgical plan. If the model
is completely transparent use the transparency slider to adjust the transparency
setting.
Failure to properly manipulate an image can lead to an ineffective preoperative
surgical plan. Users must be trained and qualified clinicians who are familiar withthe use of the HoloLens 2 in an AR environment, AR manipulation of objects, andthe Sira Medical Augmented Reality Application.
Merging models with scales mismatched can result in an incorrect preoperative
surgical plan. The software automatically resets the scale of item 2 to match item 1.
Please confirm position and try again.

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2. Safety Advisory

3 Logging Off

Warning!

Double check to make sure you have logged out of the Sira Medical application
when done. Failure to logout can lead to model manipulation by others andultimately an incorrect preoperative surgical plan.

4 Image Display
As with any imaging modality, models may hide clinically relevant data leading toan incorrect preoperative surgical plan.
Warning!

5 Critical Anatomy

Warning!

Warning!

Reviewing a model while using the wrong orientation can lead to an incorrect preoperative surgical plan. Double check to make sure the orientation is appropriate
for proper preoperative surgical planning.

This application is designed for HoloLens 2 manufactured by Microsoft. Use of
these models with other head mounted devices can lead to poor model display andan incorrect preoperative surgical plan.

6 Other Issues

Warning!

Warning!

Unauthorized access to the HoloLens 2 captured sessions could lead to an incorrect
preoperative surgical plan. Users should take action to prevent unauthorized access to the HoloLens 2 files and always have a trained and qualified clinician review
output screenshots or video prior to clinical use.
Cybersecurity breach could result in unauthorized access to the Sira Medical Augmented Reality Application and the Microsoft OneDrive account which could lead tolost or modified 3D Models and ultimately an incorrect preoperative surgical plan.
Always inspect 3D models prior to use. If any anomalies such as unexpected labelsor colors in the model are noted, contact Sira Medical Customer Service for model
correction. Always check the Microsoft Store for the latest security patch updates to
the Sira Medical Augmented Reality Application.

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2. Safety Advisory

7 Hazardous Situations Associated with Use of Applications
As with all network-connected applications, some hazards may be introduced by installing andrunning the Sira Medical Augmented Reality Application. While cybersecurity has been carefully
considered during the design and testing of the Sira Medical Augmented Reality Application, the useris advised to work with their IT department to ensure that network connection hazards have been
considered and appropriate measures and policies are in place. The following information is a guidein assessing potential risks from use of a network-connected application and includes general advice
on use of applications in a network-connected environment.
• Maintain physical control of HoloLens 2 with the Sira Medical AR app at all times. Add a physicallock to the USB-C port to prevent unwanted connections. Disable Bluetooth while using theapp to improve security.
• Failure of the network or network access will limit the application’s ability to access anddownload 3D model files but does not present any additional risks.
• The network should be configured for appropriate security including firewalls, user
authentication, and other standard methods of access control. The application does not
require any special network configuration other than access to a OneDrive location andMicrosoft voice transcription services.
• Normal network security practices should be applied. Medical devices and medical databases
should be segregated on a network separate from business functions. All data transfers should
configured to use encrypted protocols like HTTPS where possible. Always change default accesscredentials upon receiving new medical devices or networking equipment.
• The HoloLens 2 platform should be configured for controlled user authentication to control
unintended access to model files in accordance with the user’s security policies. Enforce useof complex passwords coupled with multifactor authentication. A password manager can
automatically generate complex passwords, verify sites you visit and insert usernames andpasswords in web forms. Always follow manufacturer recommendations for any identity andaccess management solutions used in your networks and edge devices (including HoloLens 2).
• Reduce your attack surface by assigning role-based access controls and administering accessbased on least privilege required to accomplish a task. Establish a system access control list
for the local storage folders on HoloLens 2 to enable file system auditing for 3D model and log
files.
• Set a group policy for USB devices to disable all but charging functionality (./Device/Vendor/
MSFT/Policy/Config/Connectivity/AllowUSBConnection = 0).
• The HoloLens 2 platform should be configured for minimum inactivity lock timeouts to control
unintended access to model files in accordance with the user’s security policies.
• Enable automatic updates to Windows, networking software and applications to maintain a highlevel of security.
• Routinely scan your networks and edge devices for malware. If you use a Bluetooth or USB-C
keyboard and/or mouse with your HoloLens 2, screen for malware before attaching to
HoloLens 2.

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Sira Medical Augmented Reality Application User Manual• Use OneDrive for Business instead of a personal OneDrive account for transferring Sira Medical
3D model files.
• Operate HoloLens 2 in a secure area free of potentially interfering equipment (radio frequency
generators).
• Use of the Sira Medical Augmented Reality Application on a network could result in previously
unidentified risks to patients, users, or third parties as a result of unauthorized access to the
network or cybersecurity breach. Employ appropriate security policies and methods. The
user is advised to identify, analyze, evaluate and control these risks as appropriate to theirenvironment.
• Subsequent changes to the network could introduce new risks and require additional analysis,
including:ºchanges in network configurationºaddition of items (hardware and/or software platforms or software applications) to the
networkºremoval of items from the networkºupdate of hardware and/or software platforms or software applications on the networkºupgrade of hardware and/or software platforms or software applications on the network

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3. Installation

3. Installation
This section includes information on installing the Sira Medical Augmented Reality Application.

1 Installation
The Sira Medical Augmented Reality Application is installed through the Microsoft Store once youraccount with Sira Medical has been established. Installation instructions are below as well as on the
Sira Medical webpage: siramedical.com/hololens-installation/
1. Access the Application Link: Open the specific link shared with you. This can be done on any
device including a computer, tablet, or the HoloLens itself.
2. Authorize the Account: Ensure the Microsoft account you are using is authorized for installation.
If you are not signed in already, the Microsoft Store will prompt you to sign in. Use your authorizedaccount credentials.
3. Click on ‘Get’: Once you’ve accessed the link and confirmed your account, you will see a “Get”
button. Click this to authorize your account to install the application on a HoloLens.
• If you are doing this on the HoloLens, the application will automatically start installing.
• If you are doing this on another device, the application will not automatically install on the
HoloLens, but it will be made available to install later.
4. Install the Application on HoloLens (if you used another device for previous steps):• Open the Microsoft Store on your HoloLens device.
• Click on the ‘Library’ icon, usually found on the upper-right of the screen.
• Set the filter to show ‘Apps not installed on this device’. This should show a list of apps
associated with your account that are not currently installed on the HoloLens.
• Look for your application in the list and click on the ‘cloud’ icon next to it. This will start installingthe application on your HoloLens.
To assure a secure environment we recommend the following HoloLens 2 set up:• Follow the HoloLens 2 instructions for Multi-Factor Authentication.
• Follow HoloLens 2 instructions to enable iris authentication for individual log in to your
HoloLens 2.
• Setting inactivity lockout time configuration can be managed in the system settings and issuggested to be set at the minimum time possible.
• Follow the Microsoft instructions to assure each user is set up with their own Microsoft accountfor OneDrive access to 3D Model files.
Contact your IT department or Sira Medical Customer Service for assistance in installing theapplication and configuring your HoloLens 2 for use with the Sira Medical Augmented Reality
Application if further support is needed.

2 Application Updates
The Sira Medical Augmented Reality Application is updated through the Microsoft Store. Contact yourIT department or Sira Medical Customer Service for assistance in updating the application.

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3. Installation

3 HoloLens 2 Environment
The Sira Medical Augmented Reality Application is intended to run on the HoloLens 2 platform withversion 22H1, Build 20348.1501 or later. Reference Technical Specifications for hardware and network
requirements.
Note: Reference the Sira Medical Augment Reality Application release notes or the Sira
Medical website for latest version(s) of the Microsoft HoloLens 2 System with which theapplication has been optimized.
The Sira Medical Augmented Reality Application requires internet access to operate. The HoloLens 2
may be configured to use WiFi 5 protocols for faster internet access.
For use of HoloLens-native features in an AR environment, refer to your HoloLens 2 user instructions https://learn.microsoft.com/en-us/hololens/hololens2-basic-usage
The Sira Medical start menu includes a quality
control image intended to ensure appropriate
brightness settings given ambient lighting conditions.
The quality control image, a white, gray, and black
vertical number board up to number 9 is situatednext to the start menu icons. A picture of the quality
control image is on the right. For best viewing, adjust
the brightness settings on the left hand side of the
HoloLens 2 visor until you can see the numbers
contained in the quality control image clearly.
In low level light all numbers 1-9 on the quality control image should be visible. In medium level light,
if you cannot see the number 6 on the quality control image, consider reducing the ambient lightor moving to a darker environment. In bright light all numbers on the quality control image will bedifficult to see. Reduce ambient light or move to a darker environment.
For additional information regarding appropriate brightness settings, review Microsoft’s environment
considerations here: https://learn.microsoft.com/en-us/hololens/hololens-environmentconsiderations.

4 OneDrive Access
The Sira Medical Augmented Reality Application requires OneDrive to access 3D model files. Secured
access to OneDrive with appropriate user authentication should be configured to provide appropriate
network security. Reference the Technical Specifications section for OneDrive and network requirements.

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4. Submitting Images for 3D Modeling

4. Submitting Images for 3D Modeling
1 Establish Client Services
Before requesting a Sira 3D Model, the following must be completed:• Obtain a HoloLens 2 and set it up as defined above,• Order and install the Sira Medical Augmented Reality Application as defined above,• Establish a contract with Sira Medical for 3D Model Image Preparation services.
• Have your Sira Medical Augmented Reality Application Sales Order Number which will be required on the 3D Model Request Form,• Establish your OneDrive account for receipt of requested 3D Models,
Sira Medical Customer Service will provide a 3D Model Request Form once client services have been
set up as given above.
Note: Each model requested requires an individual request form.

2 Requesting a 3D Model
After receiving the 3D Model Request Form, complete all sections and include any special instructions
for what you would like included within your model.
3D Models are identified with a Package ID you specify. This identification should be an anonymized
ID which traces to the patient as well as the package of images which you are supplying to create
this model. In addition, each DICOM image file supplied should be identified using an anonymized
identification number which traces to the image and the patient. The Package ID and source Image
ID’s will appear on the 3D Model with the Package ID appearing first.
Upload your completed order form and DICOM images to the Sira share drive link which was provided
to you by Sira on the 3D Model Request form.

Warning!

Caution!

Submitting incorrect data can lead to a poor preoperative surgical plan. Double
check to make sure the information that is being submitted is correct. Always
maintain conventional imaging as a backup.

Make sure the information being submitted is anonymized. Always use the fieldin the Sira Medical Request Form to enter the anonymized Package ID and Source
Image IDs.

3 Receiving a completed 3D Model
Completed 3D model files will be delivered to your OneDrive directory. Sira Medical radiologist staff
use commercial and open-source software according to a Standard Operating Procedure to prepare
output files and return ready-to-view 3D files to Sira customers after a quality assurance checkperformed by a board-certified radiologist. The QA check includes verification that package IDs andimage IDs have been added, manually assigned colors match assigned colors or colors requested incustomer request form, anatomy included matches customer request form, and any special labeling

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5. Getting Started with the Sira Medical Augmented Reality Application

required by customer is included. The QA check also includes a model file and memory check,confirmation that all artifacts from the original DICOM remain, there are no artificial artifacts, andmodel image orientation is correct.
All model files use a proprietary .fbx file format. Sira Medical will contact the phone number
provided on the Request Form to obtain access information for uploading the 3D Model to your
OneDrive directory which is used within the Sira App.
Note: The One Drive directory you provided to Sira Medical Customer service shouldbe the same One Drive Account which is signed into within the Sira Medical Augmented
Reality Application.

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5. Getting Started with the Sira Medical
Augmented Reality Application
1 Network Configuration
The Sira Medical Augmented Reality Application requires internet connection and OneDrive download
capability as defined in the Installation Section above.

2 Sira Medical Augmented Reality Application
1. Turn power on by pressing the circular power button on the rear right side of the HoloLens 2.

Warning!

This application is designed for HoloLens 2 manufactured by Microsoft. Use of
these models with other head mounted devices can lead to poor model display andan incorrect preoperative surgical plan.

Note: Proper model display is subject to fully functioning head-mounted devices not
manufactured by Sira Medical. This hardware is subject to hazards typical for thesetypes of devices and should be maintained in accordance with the manufacturers’
instructions.
2. For instructions on using HoloLens 2 press the Tips button on the home menu and follow the
instructions. Setting inactivity lockout time configuration can be managed in the system settingsand is suggested to be set at the minimum time possible.
Note: Use of or opening other applications at
the same time as the Sira Medical Augmented
Reality Application could result in interferenceor unexpected closure of the Sira Medical
application. User is advised to close otherapplications prior to starting the Sira Medical
Augmented Reality Application.

3. Once finished reviewing the tips, download the application as directed in the installation section
above. Open the Sira Medical Augmented Reality Application.

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5. Getting Started with the Sira Medical Augmented Reality Application

4. Once the application is open thetool palette will be visible.
Selectby touching or air

tapping the icon on the right-handside of the screen if not alreadysigned in.

5. Select login. A login screen willappear for MS OneDrive

6. Enter your OneDrive credentials tologin.

Note: The keyboard can be repositioned by pinching one or both of the handles on theright and left side of the virtual keyboard.

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7. All models on OneDrive will be visible.
Note: UI may freeze temporarily while loading large image files.

8. Select a model to download. Package ID will be included in file name.
9. Once the file has been downloaded to the HoloLens 2, close the Add tab and view the model. The
Package ID will be displayed with the model. To ensure the model being displayed is the intended
image for the patient, confirm the package ID is as expected.

Warning!

Warning!
No Package ID

Selecting the wrong model will lead to an incorrect preoperative surgical plan.
Cross check the model package ID on the screen to make sure you are selecting thecorrect model file.

If the Sira Medical Image Preparation Service did not include a package ID or labeled it incorrectly, the Label will show “No Package ID”. Do not use a model withouta package ID as this could result in a preoperative surgical plan for the wrong patient. Contact Sira Medical Customer Service for model correction.

Note: Sira Medical’s applications and images are delivered via cloud services and speedof the application and image delivery is dependent on the speed of the network you areusing to access the applications and images.
Note: Sira Medical’s applications and images are delivered via cloud services and are
subject to cybersecurity risks typical for these types of services.
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5. Getting Started with the Sira Medical Augmented Reality Application

3 Model Manipulation/360 Degree TourThe HoloLens2 uses finger tracking. The model can be
moved by holding directly to rotate, reposition and resize.
Pinching the borders allows for rotation, reposition, andresizing will allow the user to manipulate the model.
Video example here:
vimeo.com/user203243304/
modelmanipulation?share=copy

Warning!

Warning!

Failure to properly manipulate an image can lead to an ineffective preoperative
surgical plan. Users must be trained and qualified clinicians who are familiar withthe use of the HoloLens 2 in an AR environment, AR manipulation of objects, andthe Sira Medical Augmented Reality Application.
Reviewing a model while using the wrong orientation can lead to an incorrect
preoperative surgical plan. Double check to make sure the orientation isappropriate for proper preoperative surgical planning.

4 Sizing and Resizing
Pinching the blue lines at the corners of the model will allow the user to increase or decrease the sizeof the model.

Warning!

Failure to properly manipulate an image can lead to an ineffective preoperative
surgical plan. Users must be trained and qualified clinicians who are familiar withthe use of the HoloLens 2 in an AR environment, AR manipulation of objects, andthe Sira Medical Augmented Reality Application.
As with any imaging modality, models may hide clinically relevant data leading toan incorrect preoperative surgical plan.

Warning!

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5 Layer Visibility
Selecton the right.

This can be adjusted via a slider bar positioned at thebottom of the tool palette. Visibility can be adjusted
for each sublayer between completely invisible (0%) tocompletely solid (100%) and anywhere in between.
Video example here:
vimeo.com/user203243304/
adjustinglayervisibility?share=copy

Warning!

The Sira Medical Augmented Reality Application permits transparency of models
to be adjusted from completely transparent to completely opaque. Inadvertently
making a model completely transparent can lead to an incorrect preoperative
surgical plan. If the model is completely transparent use the transparency slider toadjust the transparency setting.

6 Object Comparison
When comparing two 3D objects the tool palette will allow the user to compare the positions of two
objects in space relative to one another. If only one object is selected, it will show position in space
relative to the origin point.
If two objects are selected, it will show relative to the first object comparisons. To return to one object
inspection double click on either of the object buttons. Selectthe scene to makeandand select another model inicons visible.

Scale is relative: 1.000 is normal scale, 2.00 is twice normal scale.
• Reset Scale
Pressing

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will revert the left selected model back to its original scale of 1x.

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5. Getting Started with the Sira Medical Augmented Reality Application• Match Scale
When viewing two objects,
selectingwill set theright selected model at the same
scale of the left selected model.
• Match Position
When viewing two objects, selecting
will set the right selected model at the same
position, rotation, and scale of the left selectedmodel.
• Reset to Single Item Analysis
To remove the second item to view just a single
item analysis, double click one of the item nameboxes

7 Virtual Cut
Selecton the right. Select blue cutting plane below the model. Reposition to desired cutting

angle. SelectNote: Application will temporarily go blank for 5-10 seconds
Model will reappear with cutting plane no longer present. Model pieces can now be moved separately.

Video example: vimeo.com/user203243304/virtualcut?share=copy
Note: While segmenting a model double check to make sure the appropriate layer isbeing selected for review.

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Merging of two 3D models can be performed by clicking
on theon the left of the palette. Selecting a namefor the object, then selecting one object > clicking add> then selecting the other object. Finally click theinthe center.
Video example: vimeo.com/user203243304/merginganaugmentedrealitymodel?share=copy

Warning!

Merging models with scales mismatched can result in an incorrect preoperative
surgical plan. The software automatically resets the scale of item 2 to match item 1.
Please confirm position and try again.

8 Adding Notes, Annotations, and Labels
1. To add a note, click ononthe clipboard , or say the voicecommand “New Note”.

2. Blue circle will appear. Place thisblue circle where you would like toannotate on the model

3. Tap to place the annotation. A
screen will appear where text canbe added via voice command or
selected to bring up a keyboard.

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4. Add desired text.

9 Session Recording
Sound and video capture can be done via HoloLens 2’s built inrecording capabilities. Saying “Start recording” to turn on recordingand “Stop recording” to turn off recording or accessing the start menu
and clicking on and off the recording icon can allow the user to record
their model review session.
Failure to properly store captured images and recordingsof the preoperative surgical plan can result in difficulty inretrieval or loss of these files.

10 Logging Off
Click Sign out on the tool palette to remove access to the signed in OneDrive account. Closing theapplication or logging out of the headset will clear the current session models but will continue toallow access to OneDrive for the same user when opening the application again. In order to sign outof OneDrive, go to Add Tab

Warning!

Warning!

and click.

Double check to make sure you have logged out of the Sira Medical application
when done. Failure to logout can lead to model manipulation by others and ultimately an incorrect preoperative surgical plan.

Unauthorized access to the HoloLens 2 captured sessions could lead to an incorrect preoperative surgical plan. Users should take action to prevent unauthorizedaccess to the HoloLens 2 files and always have a trained and a qualified individual
review output screenshots or video prior to clinical use.

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6. Troubleshooting

6. Troubleshooting
Before attempting any of the below troubleshooting measures, first export the log file via
on the About tab, then restart the application or reinstall the application, confirm yourapplication compatibility with the current software, and confirm your application license.
If issues persist, please contact Sira Customer
Service. Log files can be exported from theapplication by clicking. This will placea copy of the log file in the Pictures folder thatcan be downloaded and forwarded to the support
team. Be aware that reinstalling the application willclear out the local log file, so export a copy before
reinstalling to help identify problems.

1 Common Errors
The following errors may be encountered when using the application.
Error

Details

Error 10Not enough memory
to import the model.
Aborting download

The model is too large to download. The
model file may be too large or there may be
too many model files in cache. Try restarting
the HoloLens 2 to clear cache. Contact Sira
Medical Customer Service if further support isneeded.

Error 11Not enough memory
to slice the model.
Aborting slice.

This can happen if the model is or has become
too large to slice, the model has become toocomplex with multiple slices, or too manymodels have been added to the application.
Try restarting the HoloLens 2 to clear cache.
Contact Sira Medical Customer Service if
further support is needed.

Error 12Internet connection
lost, please checkinternet connection
and try again

Model could not be downloaded due
to connection loss. Check your internet
connection and try again.

Error 30

File cannot be Loaded

The model may not appear or displays as acube object with a question mark if the file
could not be loaded. If the file is corrupted this
this may happen. The model will likely need
to be re-saved by the Sira Medical 3D Image
Preparation service and tried again.

Error Code

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6. Troubleshooting

Error

Details

Error 31

An update is available.
Please update it from
the Microsoft store.

A new application update has been released.
To ensure the latest version of the application
is being used with up-to-date security features
go to the Microsoft Store and update to thelatest release.

Error 32

A mandatory update
is available. Please
update the app in theMicrosoft store tocontinue.

A new mandatory application update has
been released. To ensure the latest versionof the application is being used with up-todate security features, it is mandatory to go to
the Microsoft Store and update to the latest
release to continue.

Error 40

Warning!
No Package ID
Do Not Use

If the Model creation team did not include
a package ID or labeled it incorrectly, theLabel will show “No Package ID”. Do not use
a model without a package ID as this could
result in a preoperative surgical plan for thewrong patient. Contact Sira Medical Customer
service for model correction.

Error 41

Warning!
Merge Not Completed
Scales have been
set to match. Pleaseconfirm position andtry again

Scales of merged objects were not the same.
Merging models with scales mismatched canresult in an incorrect preoperative surgicalplan. The software automatically resets
the scale of item 2 to match item 1. Pleaseconfirm position and try again.

Error Code2 Memory Overload Prevention
For importing models and slicing, the application evaluates the estimated memory use to execute thattask compared to the available memory remaining. If errors are encountered, the import aborts anddisplays an error message. Reference Error 10 and 11 above for further details if these errors areencountered.

3 Sira Medical Augmented Reality Application Troubleshooting
The following troubleshooting guide provides solutions for unexpected conditions. If the actions
listed do not resolve the issue, contact Sira Medical customer service.

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Issue

6. Troubleshooting

Details

Modeling is unsuccessful

If the model cannot be loaded or manipulated asneeded, request a new model from the Sira Medical
Image Preparation Service or use conventional planning
methods.

Motion tracking is notworking as expected, orobjects are not following
in visual field as expected

In an exceptionally sparce visual environment such as
an empty or overly dark room, the HoloLens 2 may havedifficulty in tracking the user’s movement and view.
Increasing light or adding some physical objects to thevisual field may improve the HoloLens’ ability to track
movement in space.

Model trimming by
proximity to the user is
not working as expected

Models should be trimmed as the viewer moves into thevirtual space they occupy. If trimming is not occurring
as expected, moving the object closer to or further
away from the headset or moving the headset closer orfurther away from the object will adjust where trimming
occurs.

Scaling is not working as
expected

Adjusting the viewing distance to the object will impact
the visual scaling result. If objects are not scaling as
expected, adjust the object’s distance to be closer orfurther away from the headset.

Object is not responding
to manipulation as
expected.

Viewing distance and scale will affect the visual result ofmanipulating an object. Adjusting the viewing distanceto the object or adjusting the object’s scale may makemanipulation of the object easier to control andobserve. An object may be downloaded again if needed.

Memory usage error
is preventing new filedownload

When an object is downloaded, it is cached locally until
the application session is logged out. If many large
files have been downloaded during the session, even if
they have been removed from the active view, they willremain in the memory cache. Closing the application
and reopening it clears the memory cache. If you are
getting an unexpected memory usage error, closing theapplication, and reopening it will clear the cache andfree up memory, allowing you to load the files.

OneDrive login is disabled

If you cancel during the OneDrive login process, youwill need to close the application using the X on the
clipboard and restart the application.

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Issue

Cannot import models
after logging out andlogging back into
OneDrive

6. Troubleshooting

Details

If the models will not import after logging out and backin, you will need to restart the application to access the
new account models.

4 OneDrive and Network Access Troubleshooting
The following troubleshooting guide provides solutions for unexpected conditions. If the actions
listed do not resolve the issue, contact your IT department or Sira Medical customer support.
Issue

Details

Unable to access
OneDrive• Verify that your network access is available andthe HoloLens 2 is connected to the internet.
• Verify that you are logged in to your OneDrive
account on the HoloLens 2.
• Contact your IT department for issues related to
network and OneDrive connectivity.

Unable to access
OneDrive• Rebooting the headset and reconnecting to theinternet and OneDrive account may clear issues
with connectivity.
• While insufficient memory is unlikely to bea cause, closing the Sira Augmented Reality
Application and restarting will clear models frommemory cache and should resolve the issue if
insufficient memory is the cause.

“No 3D objects found”• This may occur if there are no .fbx files available
in the OneDrive folder currently being accessed.
Verify the correct OneDrive account is active on
the HoloLens 2 and you are currently logged in to
the correct OneDrive account.
• If the 3D model is not showing up in your
OneDrive account from within the Sira Medical
Augmented Reality Application try accessing
your OneDrive Account via a computer browser,
refresh your OneDrive account and confirm 3Dmodel file is present. Return to the Sira Medical
Augmented Reality Application and try again. If
3D Model file is missing, contact Sira Medical
Customer Service for further support.

No model files displayedfor download from
OneDrive

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7. Maintenance

7. Maintenance
1 Regular MaintenancePatches or updates may be periodically available through the Microsoft Store. Always check theMicrosoft Store for Sira Medical Augmented Reality Application updates.

Warning!

Cybersecurity breach could result in unauthorized access to the Sira Medical
Augmented Reality Application and the Microsoft OneDrive account which could
lead to lost or modified 3D Models and ultimately an incorrect preoperative surgicalplan. Always inspect 3D models prior to use. If any anomalies such as unexpectedlabels or colors in the model are noted, contact Sira Medical Customer Service formodel correction. Always check the Microsoft Store for the latest security patch
updates to the Sira Medical Augmented Reality Application.

Refer to your HoloLens 2 user instructions for maintenance of your HoloLens 2.
Always check to assure your HoloLens 2 software is updated to address security patches https://learn.microsoft.com/en-us/hololens/hololens-update-hololens

Warning!

Unauthorized access to the HoloLens 2 captured sessions could lead to an incorrect
preoperative surgical plan. Users should take action to prevent unauthorizedaccess to the HoloLens 2 files and always have a trained and qualified clinician
review output screenshots or video prior to clinical use.

2 Sufficient Memory
Maintain adequate storage space on HoloLens 2 to provide adequate image storage memory andclose other applications before using the Sira Medical Augmented Reality Application to provide
adequate working memory.
The application performs cleanup of locally cached files at startup and shutdown, however if an issue
is suspected with local memory, locally cached files can be deleted using native HoloLens 2 features.

3 Cybersecurity End-of-Support
Cybersecurity support for the Sira Medical Augmented Reality Application will end concurrently with
Microsoft’s end of cybersecurity support for Windows 10 Holographic. At that time a Sira Medical
Augmented Reality Application update to address vulnerabilities may not be possible.

4 Product End-of-Life
The Sira Medical Augmented Reality Application will be decommissioned through the Microsoft
Store. When the application reaches end-of-life, users will be informed through the Sira Medical
support web page. The application may be safely deleted from HoloLens 2 without risk of personalor health related data disclosure because all health data is anonymized. In addition, the Sira Medical
Augmented Reality Application does not have a save feature and any data in cache is cleared when
the application is closed. Models available for use in the application will remain in the OneDrive
account and remain unaffected by deletion of the application.
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8. Symbols 9. Contact Us

Note: Management and maintenance of the 3D Models users store in their OneDrive
accounts and video session recordings/image captures stored in the user’s HoloLens 2
is outside of the Sira Medical Augmented Reality Application and is the responsibility of
the user.

5 Export Logs
The

button in the “About” tab allows you to save a record of the application’s activities.

When clicked, a detailed log file named “SiraLogs.txt” is created in your HoloLens’ Pictures folder. Thisfeature is valuable for troubleshooting and reporting issues for support.

8. Symbols
Warning or Caution,
Consult Accompanying
Documentation

Unique device identifier

Consult Instructions for Use

Caution: Federal (USA) law
restricts this device to sale byor on the order of a physician

Safety in MRI Not Evaluated as the Sira Medical Augmented
Reality Application is software and is not intended to be
used in the MR environment.

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Contact usContact Sira Medical Customer Service at:Company:

Website:Address:

Sira Medical, Inc.

www.siramedical.com

14 Stanford Heights Avenue

Phone:

Email:(415) 740-3009

Help@SiraMedical.com

Customer Service Phone:

Customer Service Email:(415) 740-3009

Help@SiraMedical.com

San Francisco, CA 94127

Electronic version of this manual can be found at: siramedical.com/support/getting-started
All product designations and company names are trademarks or registered trademarks of thecorresponding companies.
Sira Medical, Inc. reserves the right to modify the design and specifications contained herein without
prior notice.